Trial intelligence / Profile preview

Bioequivalence Study of TJ101 Injection Before and After CMC Change in Healthy Adult Male Subjects

NCT07300436Phase 1Completed

Sponsor
TJ Biopharma
Start
Jan 2026
Primary completion
Mar 2026
Modality
Fc-Fusion Proteins
Countries
1
01

Overview

Phase 1, randomised, open-label trial of eftansomatropin alfa in growth hormone deficiency (GHD) (2 arms), sponsored by TJ Biopharma. Primary endpoints: Maximum Observed Plasma Concentration at 10 days and Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity at 10 days. Started Jan 2026; status: completed.

02

Drugs

eftansomatropin alfa
03

Conditions

growth hormone deficiency (GHD)

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